NCT03599206

ONES Grant: CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability

CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Robert Tighe, MD · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study to understand how environmental and genetic factors may be involved in lung function. Study participants will undergo a 1-day screening that includes a blood draw and breathing testing, return for a two-day series of testing to include blood draw, and brief breathing test before and after an inhaled challenge with either filtered air (FA) or ozone (O3). Participants return the next day for a brief breathing test, a blood draw and a procedure called bronchoscopy to evaluate the lung after the challenge. Participants then return 18 - 20 days later to repeat the two-day series of testing to be challenged with the exposure not received on the first series, (FA or O3). Each visit will take about 3 - 3.5 hours. Follow-up phone calls from the study team will occur at 24 hours after each 2-day test series. Total study duration is about one to one-and a half months.

Conditions

• Environmental and Genetic Factors on Lung Function

Interventions

Type	Name	Description
DRUG	Ozone	Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
OTHER	Filtered Air	Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.

Timeline

• Start date: 2019-08-16
• Primary completion: 2023-11-29
• Completion: 2024-01-24
• First posted: 2018-07-26
• Last updated: 2024-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study